Six-Month Data Presented for Abbott Vascular's Esprit BVS

January 22, 2014—Six-month results of the ESPRIT I trial suggest that the drug-eluting Esprit bioresorbable vascular scaffold (BVS; Abbott Vascular, Santa Clara, CA) appears to be effective in opening blocked blood vessels in the legs and pelvis. The data were presented at ISET 2014: the 26th annual International Symposium on Endovascular Therapy in Miami Beach, Florida.

In the ISET press release, ESPRIT I Principal Investigator Johannes Lammer, MD, commented, “The 6-month results are very promising—we’re seeing zero restenosis in the first patients to receive the BVS in the peripheral arteries, the vast majority of whom suffered moderate to severe pain while walking prior to treatment and had very little to no pain after treatment. The BVS combines the best of proven treatments while avoiding some of the problems. It opens arteries and prevents restenosis, then resorbs into the blood stream so there are no stent breaks, no prolonged irritation or delayed in-stent restenosis, and no interference with magnetic resonance imaging or surgery.” Dr. Lammer is Professor of Radiology and Director of the Division of Cardiovascular and Interventional Radiology at the Medical University of Vienna in Vienna, Austria. In October 2013, Dr. Lammer presented preliminary data from the ESPIRIT I trial at the VIVA 2013: Vascular Interventional Advances conference in Las Vegas, Nevada.

As summarized in the ISET announcement, the study of the Esprit BVS was composed of 35 patients who were treated for blockages averaging approximately 3.5 cm in length. Four patients had blockages in the pelvic iliac arteries, and 31 patients had blockages in the superficial femoral artery. At 6 months after treatment, all of the arteries in the 34 patients who were followed remained open, with the narrowing reduced from an average of 80% before treatment to 13% after treatment. Before treatment, 32 patients (91%) had moderate to severe pain while walking, and no patients were pain-free. At 6 months after treatment, 29 patients (85%) had no pain while walking, and only one (3%) had moderate pain.

According to ISET, the Esprit BVS looks and works like a stent to open up blocked arteries in the legs or pelvis while the drug coating prevents restenosis. The scaffold is a temporary structure that naturally dissolves into the blood stream within 18 months to 2 years. The BVS is made of polylactide, which naturally resorbs into the blood stream and has been shown to be safe in other medical uses, such as for dissolving stitches. A version of the device has proven beneficial in treating blocked heart arteries, noted ISET announcement.